Job Title: Associate – Regulatory Affairs
Employment Type: Contract (Duration: 1 year)
Location: Chennai
Experience: 0–6 months
Roles and Responsibilities:
• Work with local operating companies to provide regulatory review and approval of formulations, raw materials, and their constituent information to ensure completeness, accuracy, and compliance.
• Responsibilities include verification of:
▪ Trade name
▪ Manufacturer
▪ INCI name
▪ CAS/EINECS #
▪ Percentage of constituent
▪ Regional and global regulatory requirements
• Evaluate the potential impact to regulatory compliance and/or reporting/documentation requirements; interact with the appropriate J&J personnel.
• Evaluate formulations for innovation platforms, new product development, and marketed products to ensure compliance with local regulations and internal J&J standards.
• Prepare and compile required documentation, working with cross-functional partners, as required.
• Work with Client’s PR&S DRI’s to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.
• Use existing best practice documents for the raw material/RMQ review process.
• Use existing best practice documents and work instructions for raw materials and formulations review and approval process.
Deliverables:
• Regulatory compliance evaluation of new raw materials, existing materials, and change-impacting materials in the portfolio, as well as reporting/documentation requirements.
• Regulatory compliance evaluation of formulations for innovation platforms, new product development, and marketed products.
• Provide weekly updates to Client’s PR&S DRI’s.
• Provide training and education to Provider offshore resources.
• Conduct portfolio survey.